Shafi Ahmed wants to put an end to the global shortage of surgeons

The Lancet Commission on Global Surgery released a report in 2015 stating that about five billion people worldwide didn’t have access to safe surgery. Shafi Ahmed is trying to change that. He teaches surgeons around the world either using technology or flying to med schools in different countries.

Shafi Ahmed is a laparoscopic colorectal surgeon at The Royal London and St Bartholomew’s Hospitals, a trainer, educator and teacher, innovator, entrepreneur and an evangelist in augmented and virtual reality. A futurist who is the Associate Dean of Bart’s Royal London Hospital, the biggest hospital in western European and one of the oldest hospitals in the world, founded in 1123.

Fun fact: This was the place where Sir Arthur Conan Doyle’s Sherlock Holmes and Dr Watson met for the first time. And if Sherlock had his magnifying glass, Shafi has Google Glass, Google Cardboard, Snapchat Spectacles and is open to try all sorts of headsets that may help him share. Share his knowledge and his experiences.

In 2014, using Google Glass, he removed a liver cancer under the far away eyes of 13,000 students from 113 countries, who were sending Ahmed questions shown on his Glass. He read and replied just by speaking as if they were next to him.

The global shortage mentioned on the 2015 report means that milions of surgeons, anaesthetists and obstetricians will need to be trained over the next decade. Medical Realities, the company Ahmed founded in 2015 together with Steve Dann, launched its platform this week and will enable Ahmed to teach remotely using 360-degree streaming.

Shafi Ahmed accepted my interview request one day after Medical Realities was launched and told me a bit about this project and his future plans.

Yesterday you launched your platform Medical Realities. How much of an accomplishment was it?

Shafi Ahmed — Basically, it’s a major achievement. It disrupts education forever. This is a new way, a new paradigm of learning. What we’ve done with our VR platform is change the way that people might be taught and learn in the future, not just medicine but everything. So, VR and 360 video, people are still figuring out what it means. You take the video, you look around, that’s fine, that’s immersive. You take CGI animation. What we’ve done as a company, we’ve spent 9 months working with 20 developers and clinicians and CGI animators, etc. So, what does the VR mean? Hack and create learning in this environment. We spent ages thinking about the value and the validation of that system. Now we released it, everyone who’s seen it understands where VR can be of benefit. Before yesterday, no one knew where VR was going, there was no content. It’s hardware, it’s a bit of software. So, we’ve created a way that others now can create content that’s going to be valuable. So, I think it’s a big change, a complete change of direction of future learning. It is that big. I went to my team today and congratulated them for changing the whole paradigm of learning.

You also opened the OR to other professionals. Is there someone recording? How does it work?

SA — I have a team and we have a rig above the patient in the OR which we can record. That streams live into any mobile phone device. So, you can watch what’s happening around the operating theatre in real time in a VR headset, live. That’s how it works.

When we think about recording an operation live we think about al the trouble you face around the world with telemedicine and privacy and legal issues. Have you found any and, if so, how did you manage to get past them?

SA — First of all, the hospital I work in, the Royal London Hospital, which is part of Barts Health Trust, they’ve been very supportive. My hospital is the biggest hospital in western Europe. It’s huge. It’s one of the oldest hospitals in the world, a thousand years old. We are taking this institution on a journey in innovation. And what they said to me was, rather than say “no, there are too many issues”, they said “how do we make it work? What do you need to make it work?”. And so, we looked at the ethics, the privacy/confidentiality, we think about the legal framework, and all those things. What we do we innovate and do that at the same time, rather than going one by one thinking how we can make this work. I guess a lot of the questions around privacy and confidentiality and things haven’t really been answered, we are way behind technology, right? We know that. If you ask the right questions, you get the answers. Our patients are really supportive, they give explicit consent to me to do an operation live around the world and stream. They are very supportive and that makes a difference. So the legal framework supports that. As long as you’re open and frank and honest and patients supporting it with explicit consent then there are no issues. When we first started we delayed the operation by 30 seconds, in cases of major catastrophe or complication, but we’ve done so many now they don’t bother, it’s just understanding that the cameras being around you, the team working in environment, just make sure that when we go live the whole thing looks professional and the team’s working well so the public when are watching it think that this is a good learning experience and very professional which is what we’re trying to showcase.

A lot of the operations are on cancer patients. Is there a special reason for choosing oncology?

SA — I’m a cancer specialist, so, my patients have cancer diagnosis. I think cancer is universal, everyone understands cancer around the globe, the treatment is standard and it’s a certain standard around the globe. So, when the patients have cancer and they agree to have an operation shown live that’s a big emotional thing they’re giving, right? Around the world, everyone understands and it captures imagination. It’s just the practice I have, I mean, if I was doing another speciality it would be something else. It just happens I’m a cancer specialist and my patients all have got cancer that require surgery and they support me.

You don’t just take it on a virtual scale where people can watch what you’re doing. You go around the world, you go to several hospitals worldwide and teach this in person…

SA — I do a lot of work around the globe in many countries: Bangladesh, Pakistan, India, Sri Lanka, Egypt, Palestine, the Middle East, Africa, many places. Just show that a lot of my interest is about global education, global health, how do we democratize education, how to scale it up, and how to use these technologies to empower people around the globe, how to make it easier, how to make healthcare more equitable. And how to train not just one surgeon, not two surgeons, but thousands at a time, and share that knowledge.

Your next step is the virtual patient. You really want to operate on a virtual body. How far or close are you to get to that point?

SA — A long way. What we are trying to create first in virtual world is a virtual patient in photo real avatar imaging CGI so it looks realistic in front of you in a virtual environment. Then we have to place all the organs inside and then you’ll be able to operate on that virtual patient. That requires some haptic feedback, to be able to feel, to be able to operate. So, the whole thing would take probably about 2 to 5 years, maybe a couple of years to get in a position where you can do something on a virtual patient.

Your first operation using Google Glass was in 2014. What has changed from that first experience to the latest one?

SA — I guess that first experience was really experimenting with new technologies and it was a test on whether we could do this. It was new, it was a little bit, I guess, unknown. On that day, we taught 14 thousand students across the globe using the Google Glass. Since then obviously AR (Augmented Reality) which is what Google Glass is, has changed to VR (Virtual Reality). VR has come in, it’s new, it’s more different, it’s more immersive. And I think with that experience now of live operating around the globe and teaching, we have a great platform and I guess we have a worldwide recognition. Many things have changed, including people’s understanding acceptance and VR allowing different kind of learn experience. I guess we’ve just moved on and we matured with that experience.

A lot of people in China were watching you from their desktops, some people in other countries were wearing their glasses or smartphones…do you have those numbers?

SA — I’ll tell you the story. What happened was when we were doing the VR operation last April 2016, half hour before the operation we got a phone call from the main broadcasting channel in China saying “we heard about what you’re doing, we love it, we want the feed to give out to 1.2 billion Chinese people. So we thought “what will we do?”. Because we only had a certain bandwidth, we had so much storage capacity in our servers and we said “ok, we’re not sure what’s going to happen but we don’t want to overtake the whole server and crash everything”. So, we increased the volume to 200 thousand but what they did actually they took the feed off our servers up into their servers in China. So we have no idea of how many people tuned in. It may have been hundreds of thousands. We have no idea.

That wasn’t your last broadcasted operation…

SA — No. My last big one was as Snapchat one I did in November using Snapchat Spectacles. That was the last one in terms of global broadcast.

Shafi Ahmed is known as The Virtual Surgeon

So, you’re trying different platforms. Would you say that you would try all of them or focus on just one?

SA — Google Glass was great when it came out. Great device, live streaming, easy access on your head, light device, very powerful computer, and you can text people on their phone, we can see them when they message on the screen, nice interaction. VR means less interaction for you, interaction for everybody else because they’re immersed in the VR world. It’s high fidelity but low cost with your smartphone, your app and your Google Cardboard. Snapchat was another experiment. If you look at my students around the globe, there’s about 150 million active daily snapchat users. I think it’s the most powerful Augmented Reality platform that’s out there. It’s the biggest one. We don’t think about it as Augmented Reality but it is an Augmented Reality platform in light of its filters and things, right. So, 75% of the users are between the ages of 17 and 25. If you look at my medical students, that’s the age they are. They use these social media. Social media to me is a way of accessing people. Everybody has a free APP on their phone, one click can access millions of people, if you want to. Ease of access, connecting human minds, right? When I used Snapchat Spectacles, Spectacles came out, it allows you to record in 10 second clips, so my view is: can you teach people in 10 second segments? We have to think about what we’re trying to say, record it, push it out in 10 seconds. It’s short, it’s sharp and it makes sense. So, it was an experiment to see whether that would be able to enable people. I thought I don’t want to get global on this one, I’m sure if I use social media I’d be uneasy about how social media might look using this device. We were viewed by 2 million people, it had over 100 thousand downloads on youtube. I’ve met every magazine and newspaper in the world, just based on simple spectacles and a 10 second clip. Time magazine covered it, every magazine around the world, including Cosmopolitan, which is really amazing! Disruptive!

I was watching one of your surgeries on Facebook Live and I’m not a big fan of blood…

SA — You saw that! In Bangladesh. Facebook, remember, has 2 billion active users daily. That’s a third of the population. So, if you want to access human beings and train them and provide knowledge, there you are: one click on Facebook and you access the entire world. That’s what I was trying to show. In Bangladesh I did a Facebook live operation and 10 thousand students tuned in immediately. Straight away! You’re accessing people and teaching around the globe. And that’s the beauty of social media platforms. And I think we’re not using them the right way. You can take pictures of your cat, your dog, your food and your travelling and that’s great. But there’s something more powerful behind that message and it’s about connecting people and sharing your knowledge. You have knowledge, I have knowledge, we want to share the knowledge. So we share with one or two people, we feel empowered, because we are sharing what we’ve learned experience wise. But why not share knowledge with 10 of thousands of people? That has much more impact and to leave a legacy. That’s my view.

More than just educating, you’re allowing families and future patients to watch the surgery. How important is that to someone who is about have surgery or has a loved one being operated on?

SA — One of the things about surgery that is trying to change is to demystify surgery. I know that surgeries are bit secret, you have the mask, you’re in the theatre, no one knows what is going on. There’s a certain amount of mystique about surgery, which we share. I think we keep it like that on purpose so people don’t understand what we do. I think when we do this, be open, be transparent, bring people to the operating theatre, this is what we do, this is who we are, we’re human beings, we help people, the team around you is working. It’s good to showcase that whole side of surgery because people then understand. The story that I share with you is when I did a live virtual reality operation last year, I finished the operation, which was a cancer operation, I came out of the operating theatre, there were lots of news cameras and TV cameras that I had to push away, I get to the other end of corridor and I met the wife and children of the patient I that I had operated on. So I say to them “How did you find it, how did you feel?” and they said “thank you very much Mr Ahmed, we watched the operation live. Thank you.” My jaw dropped, I’m not kidding. I didn’t know what to say. That was the last think I thought I’d hear. So I said “How did you feel? I didn’t realize you were watching it”. And they said something very interesting: “It helped us. Because normally when your loved one goes for an operation, you go away to have a coffee for 3 or 4 hours, you’re pacing up and down, you’re anxious and everything else. On this occasion, we were watching the operation live, we could see what you were doing and we were reassured he was good hands and things were going well. We were happier.” And I didn’t expect that at all in any shape or form. In some way, because we hadn’t asked the question we didn’t get the answers. We assume patients want different things. Just ask the patients: “what would you like? How would you want to be treated? Do you want to watch your operation?” And actually the answers might be more surprising than we’d imagine.

Read on HunHu

Ethical companies are more profitable, says CEO of Volkov Law

Former US Attorney Michael Volkov is one of the most prominent voices in the United States when it comes to adopting compliance policies in large organizations. After 17 years in court dealing with unethical companies, Volkov decided to be a consultant to companies interested in knowing the intricacies to become examples of obedience to the law. The culture of ethics must be transversal to any type of company. And the healthcare industry is no exception, advocates Volkov Law’s CEO. He says companies and healthcare professionals are increasingly under the crosshairs of the DOJ’s new policies, with more aggressive surveillance and heavier penalties.

Michael Volkov: We are on a path to greater compliance “enlightenment” — it will be an incredible journey.

  Passionate about traveling, arts and philanthropic activities and an avid tennis player, Volkov agreed to answer the following questions in July 2015.

You started your law career in 1982 and since then a lot changed in politics, law, ethics and compliance. What would you say were the main changes?

Michael Volkov — Over the course of my 30 year career, I have seen significant changes in politics, law, ethics and compliance. First, there has been a huge increase the volume and nature of criminal prosecutions of companies and individuals for white collar offenses, including bribery, fraud, AML, and antitrust violations. Criminal prosecution has replaced civil prosecutions as the primary engine of enforcement, deterrence and prevention. Second, in response to this significant trend, the last ten years has seen the risk of the compliance professional and the increasing importance of compliance as an established corporate governance function. With increasing criminal liability for individual executives and managers, companies have turned to internal ethics and compliance programs. Compliance professionals are the most sought after professionals for many industries right now, including pharmaceutical, medical device, service providers (e.g. hospitals), financial institutions, and oil and gas companies.

How does your past experience as federal prosecutor help you nowadays?

MV — My prior experience as a federal prosecutor has put me in a unique position — I am able to work with companies to institute proactive documentation and operational systems to prevent criminal liability for the company and individuals who work at the company. I know what types of evidence a prosecutor looks for and needs to build a criminal case, and I help companies to create systems that generate information to “negate criminal intent.” In other words, I make sure that there is record evidence to show that the company took great efforts to not act like a criminal organization.

You said “ethical companies are more profitable for numerous reasons”. Could you elaborate on that?

MV — I regularly advocate that companies committed to compliance should start with creating an ethical culture first — the best compliance control that a company can create and implement is a culture of ethics and compliance. No compliance system is perfect, and the most effective constraint on possible code and legal violations is a culture of ethics. Companies that have an ethical culture have lower incidents of misconduct and are more likely to report misconduct internally.

On the overall profitability, I have found research studies that show ethical companies are more profitable. This conclusion is fairly obvious — employees are happier at ethical companies because they believe in the organization and its leadership; employees are more productive and less likely to leave an ethical company — with lower turnover rates and higher productivity, companies are more likely to increase financial performance and profitability.

Some companies are repeat offenders, others create their own compliance codes but still they don’t practice what they preach and just use them as “window dressing”. Will that ever change? How?

MV — You have identified two of the biggest compliance problems across many industries — repeat offenders suffer from serious cultural deficiencies which usually reflect a disregard of compliance by the board, the CEO and senior management; and “paper compliance programs” which are those that are on paper but not implemented in practice. Both problems continue to plague companies — I see more paper programs than recidivists. Collateral consequences to companies that violate the law are increasing — shareholder lawsuits are rapidly increasing in number and demands. As a result, companies are realizing that spending money on compliance is a good investment over suffering serious consequence from criminal enforcement by the government and collateral consequences in private litigation.

From a corporate risk perspective, the greatest legal and compliance risk has to be the False Claims Act. Could you explain why?

MV — Companies in the healthcare sector, along with pharmaceutical and medical device companies face serious risks from the False Claims Act. First, the FCA enforcement program has been around for over 150 years; there are huge risks that relators/whistleblowers have in terms of financial rewards to report on companies that are earning revenues from fraud against the government. Second, the penalties are severe for FCA violations — each false claim is trebled (tripled) for damages calculations and can quickly add up. Third, and most significantly, a company cannot challenge the government’s enforcement action because if it loses they can be “excluded” from participating in federal healthcare programs. For most companies, they cannot survive without government reimbursement programs for healthcare services, and they have to settle the case rather than go to trial against the government.

The FCA risk has grown over the last five years as the Justice Department and the Inspector General for Health and Human Services have collected multi-billion dollar recoveries each year against healthcare providers (e.g. hospitals and doctors), and pharmaceutical and medical device companies.

In Brazil we have someting called “delator” which is similar to whistleblower. However, I believe there are some differences. Could you tell us a bit more about the role of the whistleblower? Is it an important role from an ethical point of view?

MV — Whistleblowers/Relators play a critical role in bringing False Claims Act cases. A relator will file a case under seal (meaning non-public) and inform the government of the filing and allegations. The government will review the case, and if they decide to join the whistleblower’s lawsuit, the government wins 99 percent of all of its FCA cases. This mechanism and procedure is the fuel for FCA enforcement and has been increasing each year. Whistleblowers have a financial incentive and are protected legally from retaliation. Companies have to be very careful when interacting with whistleblowers to ensure proper treatment.

You say that “CCOs in the healthcare industry need to be elevated and empowered. They have the title, they lack the resources, and they need to have a message of support sent.” What do board rooms need to do about this?

MV — CCOs in the healthcare industry have a very unusual history. Long ago, in the 1990s, the government recognized the importance of empowering an independent and separate CCP from the legal department. They insisted in every settlement that the CCO be separated and given greater authority outside the legal department. Unfortunately, in practice, the CCO has become a “backwater” player with inadequate authority and resources. Only now are we seeing some improvement in the stature of the CCO in healthcare companies.

Corporate boards have been asleep on many of these issues and have failed to proactively address the problems. With an aggressive enforcement environment, some boards at the larger companies have begun to address this issue and demand improvements in overall compliance functions, including elevating the CCO to a new role.

Do you really think that the lack of board commitment is the missing ingredient in making the healthcare industry more ethical?

MV — Yes, I do. I see “lip service” to the importance of ethics and compliance but there is little follow through on the issue. Corporate boards need to become more active in exercising their oversight and monitoring responsibilities.

Since 2010, in response to scandals and prosecutions in the healthcare sector, companies have had to separate the chief compliance functions from the chief legal officer. With that separation of the CCO and the legal function came a decrease of importance of the CCO. How can the healthcare industry turn CCOs into CCEOs?

MV — With the leadership of corporate boards, the CEO and senior management, healthcare companies have to elevate and empower the CCO function with authority, resources, and accountability for performance.

In 2014, the DOJ and HHS-OIG announced charges against individuals in several cities for Medicare fraud schemes involving approximately $260 million in false billings. Almost a third of those individuals charged were doctors, nurses, and other medical professionals. How would the CCO or the CCEO stop this from happening?

MV- Most of these criminals operate at a level below where compliance officers operate, meaning they work for themselves or small companies without a compliance function. These targeted fraud prosecutions are nothing more than common criminals using the healthcare system to steal money and commit fraud. These cases do not involve larger companies or medical organizations where compliance functions are operating.

You defined the five steps that the DOJ is using to fight healthcare fraud: 1. Focus on Providers, 2. Following the Money, 3. Using All the Tools, 4. Charging Professionals, 5. Quality of Care. Could you explain how each one works?

MV — Right now, DOJ relies on a pay and chase model for fighting fraud. In other words, they pay the provider, then check out the provider based on patterns and amounts of payments, find out he or she is committing fraud, and then seek/chase the provider to prosecute criminally and/or civilly to recover funds. The pay and chase model, by definition, is inefficient and unsuccessful as a real deterrent to stop fraud.

DOJ is prosecuting, after the fact, doctors and other providers for fraud but still losing money in the equation; using the full complement of criminal investigatory tools (undercover recordings, informants, search warrants, etc), and now bringing criminal and civil cases for poor quality of care as a type of fraud committed against the government, meaning that they are not providing minimum quality of care to patients but charging the patient/government for such services.

A more effective strategy is a proactive approach. Before a private insurance or public government agency pays a medical bill to a provider, there needs to be proactive due diligence steps to verify who the provider is, do they have an office, do they really provide services, and are they legally entitled to the money. The more money spent on proactive, pre-payment investigations, the more often private and public payers can identify potential fraud risks and prevent loss of any money.

I don’t know if you heard about the scandal in Brazil with Orthotics & Prosthetics, in 2014. I saw that something similar happened in the US. In 2013 the CMS had failed to stop the illegal practice of paying unlicensed providers for orthotic and prosthetic services provided to Medicare beneficiaries. a) Easy money talks and ethic walks? b) That case shows that we still have no way of learning from other countries’ mistakes or do you think that information doesn’t leave US borders?

MV — Unfortunately, incentives to commit fraud and other criminal acts are not limited by borders — criminals exist in every country and there is nothing to stop them from committing crimes in the healthcare sector. I am not familiar with the Brazil scandal involving Orthotics and Prosthetics, but I am not surprised by financial wrongdoing in this area since it is a high fraud risk area (like hospice and nursing facilities).

You wrote that compliance is not just a cost center, it is an important way to enhance the organization’s financial performance and reputational integrity. Reputation costs money or attracts money?

MV — Reputation protects a company by instilling a positive view of the company in employees, customers, suppliers and vendors — in many cases, companies suffer more from repetitional damage than financial burdens of a fine. Investing in compliance is a way to promote financial profitability by creating an ethical culture, and creating an image that the company can present to external stakeholders. That is important to promote a company with its stakeholders and its community.

“Is this right?” or “Is this legal?”. You wrote this stating that an ethical culture is much more than a compliance culture. But the law is based on moral, on what is right. How did those concepts become so far apart?

MV — I do not accept the premise of your question — what is legally correct is not necessarily what is ethically correct. The law defines legal values. The law does no define ethical values. Usually ethical values are focused on different issues and principles. Compliance with the law does not mean ethical compliance with our values. a Company has to define its ethical principles, usually with specific defined principles.

From all the cases you dealt with since 1982 both with the DOJ and private practice, can you see the light at the end of the tunnel? Is there hope for the healthcare industry?

MV — There is definitely hope for the healthcare industry. For the first time in our history, compliance is an integral part of our governance framework. There is a lot of work to be done but we are on the right path. Companies and individuals want to do the right thing — it is just a matter of dedicating resources and time and attention to this mission. The government has a lot of power and tools to make sure this happens, but all the enforcement in the world cannot bring about a dramatic change without the support, commitment and engagement of corporate boards, communities, CEOs, senior executives and compliance professionals. We are on a path to greater compliance “enlightenment” — it will be an incredible journey.

Read on LinkedIn
Read on HunHu



Sarfaraz Khan Niazi, Forbes Most Interesting Man Revolutionizing The Health World in 2014

Sarfaraz Khan Niazi is not the typical CEO. Do not expect the traditional picture wearing a tie, suit, arms crossed, in the usual leadership pose. Niazi’personality has the perfect reflection in his image. The mustache, the hats and the suspenders are closely identified with the posture of the man whom Forbes considered “The Most Interesting Man Revolutionizing The Health World” in 2014.

Native of Lucknow, northern India, Niazi is the president of Therapeutic Proteins International (TPI) — a global holding company in the manufacture of recombinant medicines, also known as biosimilars. Considered the newest frontier of the pharmaceutical industry, this market has been causing a furor in the health trade for its disruptive capacity to provide drug solutions at an infinitely lower cost. And Niazi and his companies are the personification of this process. Recently, the businessman, writer and researcher based in Chicago for over ten years, has released a new book, dedicated to his “friend Barack Obama.” He describes his efforts to make medicines affordable for the Affordable Healthcare Act, the “Obamacare.” To that end, he suggests that the US president terminates bioequivalence testing to approve generic drugs. Instead, the government should use orthogonal equivalence testing methods, which would substantially reduce the cost of introducing equivalent drugs. As a result, Niazi argues, this would substantially increase the quality of products on the market. The objective would be to increase access to biological products, which are very expensive and of high complexity, for those who can not afford it.

I had the chance to interview him in November, 2014 and I wrote a profile of him that was published in Portuguese. Here is the original interview.

Forbes called you “The Most Interesting Man Revolutionizing The Health World.” Do you agree that you are a revolutionary or at least have a revolutionary side?

Sarfaraz Niazi — Judgment is in the eye of the beholder. In our own humble way, we all try to make a small change in the world we have come into and want to leave it a better place when we depart. I am doing all I can to achieve this goal. The difference between evolutionary and revolutionary is merely the timescale.

When Forbes considers you the most interesting person in the world of health, do you believe that has a lot to do with your characteristics — poet, writer, teacher, photographer, radio host, inventor, scientist, and your expertise in chemistry, pharmacy and marketing?

SN — To experience the myriad aspects of life proves rejuvenating to me. I have always questioned everything I see because I realized very early in my life that there is no absolute standard to anything, from morality to literature to science and creative art; standards are merely customary. And, with every question that I get answered many more appear. It is almost like being a child exploring the Universe around. I stay a child in my inquiries and find that to be the most satisfying experience. Getting involved with such diverse activities as conducting a radio program that goes out to billions to photography to recombinant manufacturing, I find these diversities challenging but exciting when I am able to switch my roles — otherwise life becomes very boring.

Your books are distributed in developing countries at a lower price because they are “royalty free”. Your goal with the development of biosimilar medicines is to provide medicine like your books, low cost?

SN — Our goal is to expand access to highly complex, very expensive biologics to those that cannot afford them. We believe in providing affordable, high quality options to patients in need around the globe. Charity begins with a charitable heart and we will always give what we can.

It would be logical that the big pharmaceutical see you as “unfair” competition, but some of your investors are linked to pharmaceutical companies as Amneal Pharmaceuticals LLC? Do you think this means (some) labs are interested in producing inexpensive health solutions?

SN — The main driver for the creation of biosimilars and biosimilar regulations in countries is to provide competition to products that have been to date, monopolies. Similar to small molecule drugs expecting competition once patents have expired, biologics will face the same competition. It is not about being unfair but about giving patients alternatives once IP protection runs out. TPI is an independent company founded on that singular goal of helping the world and we shall continue our vigil.

The biosimilars are usually authorized several years after reference biological medicinal product approval, as the reference medicinal product benefits from a period of exclusivity during which the biosimilar medicines can not be allowed. This may delay the benefits that you want to provide?

SN — Just like any follow on pharmaceutical whether generic or biosimilar, a manufacturer has to wait until the patent protection expires to launch. There is a different kind of benefit provided by an innovative new product that a company invests a lot of money in to bring to market and the patent protection those products get reflects that investment.

Niazi: “we all try to make a small change in the world we have come into and want to leave it a better place when we depart. I am doing all I can to achieve this goal.”

What is the difference in production costs between the reference drug, generic and biosimilar? And the sale price to the public?

SN — This will be very depending on the market and company selling the product. In general it takes on average $1–3B to develop a new pharmaceutical, $100–300M to develop a biosimilar and $1M to develop a generic. Pricing in the market will reflect those differences in development costs.

Is the business of Therapeutic Proteins International profitable? It is comparable to a pharmaceutical?

SN — TPI is working on a robust pipeline and expects to launch products in the near future. The business model is totally different from the pharmaceutical product universe; we are making large investment in educating the prescribers and payers of the value of biosimilars.

What about the doctors’ opinion? What feedback have you gotten from doctors regarding your creations?

SN — We have solicited a great amount of feedback from prescribers and users of biologics. Generally, people in the United States are ready for biosimilars and recognize the benefits to patients and to the health care system. Feedback has been very positive. Unlike small molecule drugs where even 70–80% price reduction translates into few dollars, even a small reduction in the cost of biological drugs will make huge total dollar impact. We anticipate that once the doctors are given proper education about the robustness of the regulatory process and a better understanding about the safety of these drugs, the switch to biosimilar drugs will be automatic. As an example, France has, by legislative action made these product interchangeable for new patients. The future market of these products will be driven mainly by the payers.

Besides biosimilars, you have also created a much more economical way to produce drugs, a disposable container that replaces the metal containers. Could you explain the main difference(s) and how it works?

SN — Our process allows for the simultaneous production of numerous products in a relatively small facility with quick scale up. It eliminates the majority of the capital investments needed to develop a more traditional biologic facility. This technology opens a new possibility for the small developers of new drugs including academic institutions, governments and in situations where disaster-related drugs and vaccines are needed to be produced on demand. The key differences between our technology and the standard technology is: completely disposable, no cross-contamination, gentle treatment of living entities to produce a consistent product, extremely cost effective for start up and maintenance, very easy to switchover between batches and highly portable.

Do you believe biosimilars and other inventions that aim to lower the cost of health care would work in most developed countries wishing to reduce their costs with health services?

SN — Absolutely. There is always room for ingenuity and streamlined process in the health care space. To date, developed nations such Europe, Australia, Japan and Canada all have approved biosimilars on market and have been using them safely for years. The issue of affordability remains same for all countries; even in the US, a significant number of patients undergo financial challenges when required to use these products. In the US, a significant cost is paid by the government and billions of dollars of savings are anticipated with biosimilars coming to the US markets.

Do you have any idea of how many people can be benefited if your inventions — biosimilars and the container — are approved?

SN — Currently, biologics realize around $160B in sales globally, representing millions of patients. The potential impact of more accessible biologics is huge and millions and perhaps billions of people around world would be affected. With lowered prices, many more millions will be able benefit from these products who are not currently able to afford them, vastly expanding the market of these products.

And can you imagine how many people have been influenced by your inventions so far?

SN — My inventions always seek to provide practical value and numerous inventions have been put into practical use in various parts of the world. The real use of inventions is when the patents expire so mankind can benefit. A patent simply asserts that the invention is useful, unique and nonobvious. I hope these inventions will find greater use with spin-off devices that will arise including potable water, prevention of hospital-based infections, improved safety of automobiles and very high quality of wines that are affordable as well. The biggest influence I have been able to gather is motivating the young people to be creative, to think different and to challenge everything. And that is more rewarding than any other gain.

I could see by your blog that you are a thinker, so I would like to know what is your opinion about The Affordable Care Act.

SN — The Affordable Care Act was put in place with a similar mission, to allow all patients access to care and to bring down health care costs that are on an unsustainable path. Getting a law passed with that aim is no small feat and TPI is under the impression that patients that need access should get access. That is part of our mission as well.

Related to that, health insurance exchanges are having amazing projections to 2015. As someone concerned with the reduction of health care costs, what would you invent to help people or businesses save on insurance?

SN — Due to the complex nature of the healthcare system in the United States, insurance will also be complex but efforts to make the system more competitive will benefit the people. Additionally, preventative care mandates and the access of preventative care to a wider population has the potential to reduce the burden to the system.

Do you think it is possible to have a free and universal national healthcare system in the US?

SN — There are no free healthcare systems anywhere in the world today. In the U.S. the cost is shared by employers, patients and the government. In other places healthcare is covered by the government but the cost is shouldered by tax payers. Healthcare in the U.S. will stay a mixed system for the foreseeable future. It works very well and with the Affordable Healthcare Act it will become more universal and therefore more affordable.

How do you analyze the future challenges of the health system in developing countries like India or Brazil?

SN — There are challenges with health systems in developing countries. On one had, emerging nations find ways to do more with less. In another the quality of pharmaceuticals and care is not the same as in more developed nations in a lot of instances. To bring up the quality standards while keeping treatments costs affordable will continue to be a challenge going forward. It is unfortunate that some regulatory agencies apply the same quality standards to biological as they do to small molecule drugs and as a result, the damage to patients may be much more severe than otherwise imagined. In my new book, “Biosimilars and Interchangeable Products — from cell lines to commercial launch” that is under printing and the book, “Handbook of Bioequivalence Testing, 2nd Edition” that was released on 29 October 2014, I provide advise to developing countries on how to formulate robust policies to assure quality of biological drugs. This includes advise on using third party evaluators and ongoing surveillance of products produced locally. The regulatory agencies in these countries can develop a safe pathway but that requires a new thinking.

How do you have time to conciliate all the activities in which you engage? (Please tell me if you have invented a way to make your days last more thank 24 hours).

When you have a passion for something, you find ways to do it more efficiently and to find time to engage in those activities for which you are passionate. Actually 24 hours are more than enough. I am 65 years old, I just ran my first marathon (Chicago Marathon) and am looking forward to many years of enjoying life 24/7.

One last question. Your moustache is your trademark, it is even your Twitter profile image. Is there a story behind it?

SN — It did not start as a trademark. When I got married, 40 years ago, my wife told me to keep it and I did. I have enclosed my wedding picture here. Then I began reading Gorky and saw his unruly moustaches and unruly mind — we kind of have a great biosimilarity in our thoughts.

Read on LinkedIn
Read on HunHu